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CTRI Number  CTRI/2025/02/080587 [Registered on: 14/02/2025] Trial Registered Prospectively
Last Modified On: 12/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Catheter Related Blood Stream Infections (CRBSI) 
Scientific Title of Study   Catheter related blood stream infections(CRBSI): Incidence, risk factors and antimicrobial susceptibility in a tertiary care hospital 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr SWATI  
Designation  PG 1ST YEAR RESIDENT 
Affiliation  School of Medical Sciences and Research, Sharda Hospital 
Address  Department of Anesthesiology, School of Medical Sciences and Research, Sharda Hospital , Plot no 32, 34, Knowledge Park 3, Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  9759356614  
Fax    
Email  swatiy0102@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr RAM MURTI SHARMA 
Designation  Professor 
Affiliation  School of Medical Sciences and Research, Sharda Hospital 
Address  Department of Anesthesiology, School of Medical Sciences and Research, Sharda Hospital, Plot no 32, 34, Knowledge Park 3, Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  7798881243  
Fax    
Email  sharmarammurti@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr SWATI  
Designation  pg 1st year resident anaesthesia 
Affiliation  School of Medical Sciences and Research, Sharda Hospital 
Address  Department of Anesthesiology, School of Medical Sciences and Research, Sharda Hospital , Plot no 32, 34, Knowledge Park 3, Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  09759356614  
Fax    
Email  swatiy0102@gmail.com  
 
Source of Monetary or Material Support  
School of Medical Sciences and Research, Sharda Hospital , Plot no 32, 34, Knowledge Park 3, Greater Noida, Uttar Pradesh, 201310 
 
Primary Sponsor  
Name  School of medical sciences and research 
Address  Plot No 32, 34, Knowledge Park 3, Greater Noida, 201310, INDIA 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr SWATI  Sharda Hospital, School of medical sciences and research  Department of Anesthesiology, 2nd floor, B block Gautam Buddha Nagar, UTTAR PRADESH Gautam Buddha Nagar UTTAR PRADESH
Gautam Buddha Nagar
UTTAR PRADESH 
9759356614

swatiy0102@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Patients more than 18 years of age and, admitted in ICU with CVC catheter and HD catheter in situ for more than 48 hrs.
 
 
ExclusionCriteria 
Details  1.Patients admitted from other hospital with CVC catheter/HD catheter.
2.Immunocompromised or those with terminal or severe illness (advanced or metastatic cancer, advanced congestive heart failure, stroke, coma).

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
CRBSI is suggested when blood from the CVC demonstrates microbial growth at least 2 h earlier than growth is detected in blood collected simultaneously from a peripheral vein.  first at baseline then after 1 week 
 
Secondary Outcome  
Outcome  TimePoints 
1. To identify possible risk factors associated with CRBSI.
2.To isolate microbial agents causing CRBSI.
3. To study antimicrobial sensitivity patterns.
 
when CRBSI is suspected 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   24/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response - None of the above

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [SWATIY0102@GMAIL.COM].

  6. For how long will this data be available start date provided 10-10-2024 and end date provided 10-10-2060?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Catheter-related bloodstream infection (CRBSI) is defined as the presence of bacteremia originating from central venous catheter. It is one of the most frequent, lethal, and costly complications of central venous catheterization and also the most common cause of nosocomial bacteremia. Intravascular catheters are integral to the modern practices and are inserted in critically-ill patients for the administration of fluids, blood products, medication, nutritional solutions, and for hemodynamic monitoring. Central venous catheters (CVCs) pose a greater risk of device-related infections than any other types of medical device and are major causes of morbidity and mortality.

 

The definitive diagnosis of catheter infection can be made by using a combination of clinical signs and symptoms together with the various culture techniques. Patients with CVC catheters developing fever or chills, unexplained hypotension, and no other localizing sign suggest possibility of CRBSI. Catheter site infection is indicated by the presence of erythema, swelling, tenderness, and purulent drainage around the catheter exit and the part of the tunnel external to the cuff. Risk factors for CRBSI include immunocompromised status, neutropenia Burns, Malnutrition, BMI >40, Prolonged hospitalization before catheter insertion, emergency catheter insertion, incomplete adherence to aseptic technique, multiple manipulations of the catheter, failure to remove unnecessary catheter. The administration of parenteral nutrition through intravascular catheters increases CRBSI risk. Local risk factors, such as poor personal hygiene, occlusive transparent dressing, moisture around the exit site, S. aureus nasal colonization, and contiguous infections support the role of bacterial colonization in the pathogenesis of CRBSI.

 

The antimicrobial susceptibility patterns will help clinician to decide correct choice of antibiotics and antimicrobial stewardship. Antibiotic therapy for catheter-related infection is often initiated empirically. The initial choice of antibiotics depends on the severity of the patient’s clinical disease, the risk factors for infection, and the likely pathogens associated with the specific intravascular device. There are no compelling data to support specific recommendations for the duration of therapy for device-related infection.  Antibiotic therapy for CRBSI is used in conjunction with systemic antibiotic therapy and involves installing a high concentration of an antibiotic, to which the causative microbe is susceptible in the catheter lumen. The likelihood of success varies with the site of infection 
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